Cleared Traditional

K182259 - Gentrix Surgical Matrix

K182259 is the FDA 510(k) clearance for Gentrix Surgical Matrix by Acell, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTM) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K182259 · Acell, Inc. · General & Plastic Surgery device
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Feb 2019
Decision
170d
Days
Class 2
Risk

K182259 is an FDA 510(k) clearance for the Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on February 7, 2019 after a review of 170 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Acell, Inc. devices

Submission Details

510(k) Number K182259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2018
Decision Date February 07, 2019
Days to Decision 170 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 115d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTM Mesh, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTM Mesh, Surgical

All 44
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